Author: Rippan Shukla
Shukla, Rippan, 2024 Best predictors for a good outcome after laparoscopic fundoplication in patients with gastro-oesophageal reflux disease, Flinders University, College of Medicine and Public Health
Terms of Use: This electronic version is (or will be) made publicly available by Flinders University in accordance with its open access policy for student theses. Copyright in this thesis remains with the author. You may use this material for uses permitted under the Copyright Act 1968. If you are the owner of any included third party copyright material and/or you believe that any material has been made available without permission of the copyright owner please contact copyright@flinders.edu.au with the details.
The Lyon consensus 2.0 states that the actionable definition of gastro-oesophageal reflux disease requires conclusive evidence of reflux-related pathology on endoscopy and/or abnormal reflux monitoring in the presence of compatible troublesome symptoms (Gyawali et al., 2023). Gastro-oesophageal reflux disease or reflux disease has heterogeneous manifestations, and the symptoms range from typical, as in heartburn and regurgitation, to atypical, including chronic cough, hoarseness, asthma, laryngitis, dental erosions, and ear-nose-throat complaints. Whilst treatment of reflux disease is usually initiated with anti-reflux medications and life-style modifications, about 40% of patients (Kahrilas et al., 2013a, Sigterman et al., 2013, Sifrim and Zerbib, 2012, Savarino et al., 2017, El-Serag et al., 2010) either do not respond or show discontent with first-line treatment.
Laparoscopic fundoplication, first described in 1991, has replaced conventional open fundoplication, and is considered the gold standard surgical treatment for reflux disease. The technique involves mobilising the gastro-oesophageal junction to reposition the lower oesophagus below the diaphragm, suturing the diaphragmatic crura to repair the hiatal defect, and creating a new valve to prevent reflux of gastric contents into the oesophagus. Laparoscopic fundoplication is an effective surgery for gastro-oesophageal reflux disease and has a success rate of 80-85% in the long-term. However, the exact cause for the failure of this small, but significant 15-20% subset is not clear, even after three decades since the introduction of fundoplication. The conundrum of whether there is a single factor, or a combination of factors, that leads to recurrence of symptoms is not clearly understood.
The aim of this Master of Surgery thesis is to evaluate and identify the predictive value of preoperative factors to:
− Improve post-operative outcomes after laparoscopic fundoplication to close to a 100% satisfaction rate.
− To avoid laparoscopic fundoplication in gastro-oesophageal reflux disease patients who are doomed to fail.
This research aims to identify predictors of success prior to laparoscopic fundoplication to help the surgeon to avoid operating on patients who will not benefit from the operation. This thesis presents a narrative review of the current literature, followed by a systematic review using predictors identified in the narrative review to assess outcomes after laparoscopic fundoplication. This research tested data held in our institutional database for patients who have undergone laparoscopic fundoplication against the outcomes to validate the predictors against the same outcomes.
Through the narrative review, predictors such as male sex, typical symptoms, response to anti-reflux medication, and an abnormal preoperative pH study were found to be associated with excellent outcomes after fundoplication. Age, weight, grade of oesophagitis, oesophageal peristaltic function, and reflux patterns did not seem to affect outcomes. However, female sex, depression, atypical symptoms, long-segment Barrett’s oesophagus, morbid obesity, and delayed gastric emptying were some of the potential predictors needing further study. Elderly patients with reflux disease, patients with equivocal or negative pH studies, and pre-operative dysphagia with a hypertensive lower oesophageal sphincter were identified as pre-operative predictors requiring careful consideration. The role for delayed gastric emptying effects on fundoplication outcome was not clearly established.
Reviews included in the thesis identified the heterogeneous nature of the outcomes reported in each study. A meta-analysis was hence not possible. Although objective outcomes included endoscopy, pH study, and manometry findings to assess the integrity of lower oesophageal sphincter, the statistical methods to derive results were varied. Subjective outcomes usually assessed individual symptoms including heartburn, dysphagia, regurgitation and assessed them as symptom scores, satisfaction scores, LIKERT scales or visual analogue scales. Through extensive research based on narrative, systematic and, subsequently, database validation, it is recommended that all future studies should have at minimum the following: standardised subjective and/or objective outcomes, minimum duration of follow-up, clear definition of failed fundoplication, and similar analytical methods of statistics when reporting the results of outcomes.
The rate of successful outcomes after laparoscopic fundoplication has remained consistent at 80-90%. While the widespread principles in the technique of laparoscopic fundoplication have remained unchanged except for a few modifications in the wrap techniques (partial fundoplication for females and manometric findings of inefficient distal oesophageal peristalsis), the long-term failure rate of 10-15% has not improved.
While the demographic and pre-operative clinical factors for gastro-oesophageal reflux disease have undergone extensive investigation and thorough analysis in scientific literature, outcomes related to predictors like reflux patterns and delayed gastric emptying remain elusive and- under-researched.
Pre-operative factors play a significant role in determining the outcomes after laparoscopic fundoplication for gastro-oesophageal reflux disease. Based on literature review and systematic review, followed by our institutional based database study, there is evidence of specific predictors that should be selected carefully, even with objective confirmation of gastro-oesophageal reflux disease.
Female sex, poor or ineffective oesophageal peristalsis, and percentage of time pH <4 were identified as predictors that affect the outcome of anti-reflux surgery. Gastric emptying time and reflux patterns (based on pH studies) were found to be under-researched regarding their effect on outcomes. Whereas reflux symptoms, regurgitation, body mass index, grades of oesophagitis, non-dysplastic Barrett’s oesophagus, status of lower oesophageal sphincter on manometry did not affect the outcomes after fundoplication. Age as a factor remained equivocal and further large randomised controlled studies will help establish its effect on outcome.
The work included in this Master of Surgery thesis has contributed to greater understanding of the pre-operative factors associated with success or failure after laparoscopic fundoplication.
What do we understand?
1. Though the pre-operative work up for gastro-oesophageal reflux disease (GORD) patient requires investigation to confirm reflux disease (e.g. ambulatory 24hr pH study), careful selection of patients is imperative.
2. Patients with high-risk predictors including female sex, comorbidities including depression, delayed gastric emptying, low percentage of oesophageal peristalsis, and long segment Barrett’s oesophagus should be routinely counselled pre-operatively. The expectations from surgery should be clearly discussed and established pre-operatively.
3. Standardising subjective outcomes in future studies and implementing them in clinical practice will help streamline further research work and improve engagement of patients for long term follow up for at least 5 years.
4. Current predictors in literature have been extensively investigated and there is a need to study comorbidities associated with GORD like diabetes mellitus, obstructive sleep apnoea, irritable bowel syndrome and smoking.
Proposed future work needed on this topic is outlined in the concluding chapter.
Keywords: Gastro-oesophageal reflux disease, Fundoplication, recurrent reflux, predictors, post operative outcomes
Subject: Surgery thesis
Thesis type: Masters
Completed: 2024
School: College of Medicine and Public Health
Supervisor: A/Prof Sarah Thompson